Efficacy and Safety of SANGUINATE™ for Reduction of Delayed Graft Function in Patients Receiving a Kidney Transplant
A Randomized, Placebo-controlled, Prospective, Double-blind, Multicenter Phase 2/3 Study of the Efficacy and Safety of SANGUINATE™ for Reduction of Delayed Graft Function in Recipients of a Donation After Brain Death Kidney Transplant
1 other identifier
interventional
60
1 country
20
Brief Summary
Safety and efficacy study of SANGUINATE on reduction of delayed graft function (DGF) in patients who will be recipients of a donation after brain death (DBD) donor kidney.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2015
Shorter than P25 for phase_2
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 16, 2015
CompletedFirst Posted
Study publicly available on registry
July 3, 2015
CompletedStudy Start
First participant enrolled
August 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedOctober 27, 2016
October 1, 2016
1 year
June 16, 2015
October 26, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
Reduction of delayed graft function (DGF)
Reduction of delayed draft function will be measured by the number of dialysis sessions.
30 Days
Participants With at Least One Occurrence of Safety Composite Endpoint by Treatment Group
Composite endpoint defined by changes in vital signs, electrocardiographic, biochemical, hematological, and urinalysis, graft loss, death and other reported adverse events
Phase 2 - 30 Days; Phase 3: Safety - 90 days; Serious Adverse Events and Adverse Events of Special Interest - 180 Days; Graft Survival - 365 Days
Secondary Outcomes (6)
Proportion of subjects requiring dialysis for any reason in the first 7 days post-transplant
7 Days
Proportion of subjects requiring dialysis only in the first 5 days post-transplant
5 Days
Number of days of dialysis therapy.
30 Days
Proportion of subjects with a fall in serum creatinine.
7 Days
Proportion of subjects with a serum creatinine greater than 3 mg/dL, but who did not require dialysis by Day 5 post-transplant
5 Days
- +1 more secondary outcomes
Other Outcomes (1)
Determination of sample size for Phase 3 based upon the results from Phase 2.
30 Days
Study Arms (2)
SANGUINATE
EXPERIMENTALTwo (2) infusions of SANGUINATE
Normal Saline
PLACEBO COMPARATORTwo (2) infusions of Normal Saline
Interventions
Two (2) infusions of 320 mg/kg of SANGUINATE at Baseline and Day 1
Two (2) infusions of Normal Saline at an equal volume to SANGUINATE at Baseline and Day 1.
Eligibility Criteria
You may qualify if:
- Able to understand and provide written informed consent.
- Male or female subject at least 18 years of age.
- Dialysis-dependent renal failure initiated at least 3 months prior to transplantation.
- Subject is to be the recipient of a first kidney transplant from a deceased donor (brain death criteria).
- Is able to receive intravenous infusions of study drug.
- Anticipated donor organ cold ischemia time \< 30 hours.
- A calculated prediction of DGF risk of least 25%.
- Females of childbearing potential must agree to use 2 forms of effective birth control regimen (at least one-barrier method) during the initial 30-day study period.
- Male subjects must agree to use condoms or other suitable means of pregnancy prevention.
You may not qualify if:
- Has received a blood transfusion of packed red blood cells (PRBC), other than with leukocyte-poor blood, within the 90-day period prior to screening.
- Recipient of a live donor kidney or a kidney from a donation after cardiac death (DCD) donor.
- Recipient of donor kidney preserved with normothermic machine perfusion.
- Is scheduled to undergo multi-organ transplantation.
- Has planned transplant of kidney(s) from a donor \< 6 years of age.
- Has planned transplant of kidneys that are implanted en bloc (dual kidney transplant).
- Has planned transplant of dual kidneys (from the same donor) transplanted not en bloc.
- Body Mass Index (BMI) \> 38 kg/m2
- Is scheduled for transplantation of a kidney from a donor who is known to have received an investigational therapy (under another Investigational New Drug) for ischemic/reperfusion injury immediately prior to organ recovery.
- Is scheduled to receive an blood type-incompatible donor kidney.
- Has undergone desensitization to remove antibodies prior to transplantation.
- Total bilirubin \> 1.5 mg per dL, transaminase more than twice the upper limit of normal or evidence of hepatic insufficiency
- Has participated in an investigational study within the last 30 days or received an investigational product within 5 half-lives of the study drug administration, whichever is longest. Potential subjects participating in a strictly observational study or a study involving approved treatments should be discussed with the Medical Monitor.
- Has a history of human immunodeficiency virus (HIV)
- History or presence of active substance abuse (illicit drugs or alcohol) in the previous 6 months, as believed by the Investigator
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Mayo Clinic Phoenix
Phoenix, Arizona, 85054, United States
University of California, Los Angeles
Los Angeles, California, 90024, United States
California Institute of Renal Research
San Diego, California, 92123, United States
California Pacific Medical Center
San Francisco, California, 94115, United States
University of California San Francisco
San Francisco, California, 94143, United States
Medstar Georgetown University Hosiptal
Washington D.C., District of Columbia, 20007, United States
Tampa General Hospital
Tampa, Florida, 33606, United States
Augusta University
Augusta, Georgia, 30912, United States
Northwestern University
Chicago, Illinois, 60611, United States
UIC University of Illinois at Chicago
Chicago, Illinois, 60612, United States
Ochsner Medical Center
New Orleans, Louisiana, 70121, United States
Henry Ford Hospital
Detroit, Michigan, 48212, United States
Saint Barnabas Medical Center
Livingston, New Jersey, 07039, United States
The Cleveland Clinic
Cleveland, Ohio, 44195, United States
University of Toledo
Toledo, Ohio, 43537, United States
Central Pennsylvania Transplant Foundation
Harrisburg, Pennsylvania, 17104, United States
University of Pittsburg Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
University of Wisconsin
Madison, Wisconsin, 53706, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Hemant Misra, PhD
Prolong Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 16, 2015
First Posted
July 3, 2015
Study Start
August 1, 2015
Primary Completion
August 1, 2016
Study Completion
October 1, 2016
Last Updated
October 27, 2016
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will not share